Kornimate/medical-research-clean huggingface dataset:
interpretation of transnasal esophagoscopy findings

Conditions: Larynx Disease

Summary: the purpose of this study is to determine the prevalence of esophageal pathology in patients with voice disorders. in addition, , the intra- and interdisciplinary variability regarding the identification of esophageal pathology will be analyzed in this study.

throat symptoms are common complaints for many patients. some symptoms are thought to be attributable to laryngopharyngeal reflux (i.e. the reflux of stomach acid to the level of the larynx). it is unclear what role laryngopharyngeal reflux (lpr) has in producing throat symptoms and its relationship to laryngeal pathology. lpr may be more carefully diagnosed if knowledge could be obtained regarding the presence of esophageal manifestations of reflux of stomach acid. although lpr may occur in the absence of esophageal manifestations, the presence may make this diagnosis more probable. if so, therapy can be more carefully directed. using a flexible endoscope, otolaryngologists perform transnasal flexible laryngoscopy. this requires only topical anesthesia and occurs in the clinic setting. the small caliber transnasal esophagoscope was developed in recent years and is performed in a similar manner. it can provide key information regarding esophageal pathology. this obviates the need for administration of anesthesia (i.e. other than the topical, non-sedating agent). transnasal flexible laryngoscopy is considered to be the standard of care for evaluation of the larynx. transnasal esophagoscopy is an extension of this standard of care. there are a number of studies demonstrating the safety and utility of transnasal esophagoscopy in humans. typically these studies are composed of retrospectively on a select group of patients. additionally the tne findings are reviewed by one medical discipline. this study will be the first prospective analysis of tne in which the findings will be reviewed in a multidisciplinary manner (i.e. otolaryngologists and gastroenterologist). also, the population involved will be more general than previous studies, representing a myriad of throat symptoms.

Eligibility criteria:
inclusion criteria: * study participants include persons 18 years and older * patients presenting to the vanderbilt voice center and complaining of throat symptoms. these include hoarseness, throat clearing/pain/burning, heartburn, globus sensation, and acidic/sour taste. * new and return patients will be included. exclusion criteria: * participants who are unwilling to undergo the study * patients who have had prior esophagoscopy * those who do not sign the consent * pregnant women.
tmc435-tidp16-c119 - a study comparing 2 new capsule formulations of tmc435 to an established capsule formulation and evaluating the respective blood levels of tmc435 following single dose administration

Conditions: Hepatitis C Virus

Summary: the purpose of this study is to compare in healthy volunteers levels of tmc435 in the blood circulation after intake of 2 new capsule formulations with the level of tmc435 in the blood circulation after intake of the capsule formulation used in the phase iib studies.

this is a randomized (study drug assigned by chance), open-label (all people involved know the treatment), single dose, crossover (volunteers will receive different treatments sequentially during the trial) study in healthy volunteers. the trial will evaluate the levels of tmc435 in the blood circulation after a single dose of 150 mg tmc435 administered as 3 different capsule formulations following breakfast. there will be a 7-day washout period between treatments and a 4-5 week follow-up at the end. each volunteer will receive all three treatments. the main focus of the trial is the pharmacokinetic characteristics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of the different formulations. this evaluation requires multiple blood samples from day 1 through 72 hours after dosing. safety assessments (lab work, blood pressure, pulse and electrocardiogram) will follow a different schedule and are measured on day -1 (day prior to taking first dose of drug), day 1 (without lab work) and day 4 of each treatment period, and 1 and 4-5 weeks after the last treatment. each volunteer will receive 3 treatments, 7 days apart from each other. each treatment consists of one single oral dose of 150 mg tmc435.

Eligibility criteria:
inclusion criteria: * non-smoker for at least 3 months * body mass index of 18.0 to 30.0 kg/m2 * healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram exclusion criteria: * infection with hepatitis a, b or c virus * infection with the human immunodeficiency virus (hiv) * history of, or any current medical condition which could impact the safety of the participant in the study

Keywords: tmc435-tidp16-c119 tmc435-c119 tmc435 protease inhibitor hcv hepatitis c bioavailability
genomic signatures for patients with initially unresectable colorectal liver metastases

Conditions: Genomic Instability; Prognostic Cancer Model

Summary: a retrospective cohort of 286 patients with synchronous crlm underwent conversion therapies based on next-generation sequencing (ngs) results. all cases were categorized into a successful conversion therapy group (sctg) if they achieved no evidence of disease (ned) status through surgery after conversion therapy, and a failed conversion therapy group (fctg) otherwise. clinical risk factors and genomic mutations were analyzed for association with conversion therapy outcomes and survival.

all procedures involving human participants in this study adhered to ethical standards set by institutional and/or national research committees, as well as the 1964 helsinki declaration and its later amendments or similar ethical standards. this cohort study has been reported in line with the strocss criteria. this study enrolled 286 patients initially diagnosed with colorectal cancer (crc) concomitant with synchronous liver metastases. all patients received comprehensive treatment and follow-up at the department of colorectal surgery, first affiliated hospital of nanjing medical university between 2016 and 2018. at diagnosis, all patients met the criteria for preoperative conversion therapy, with a cancer recurrence score (crs) of ≥3. patients were excluded if they: i) could not tolerate a full course of systemic therapy; ii) had a history of other malignancies; iii) had previously undergone cancer treatment; or iv) patients who were not rendered disease-free at time of hepatic resection (i.e., primary intact, unresected extrahepatic disease, or gross \[r2\] residual hepatic disease) were excluded. next-generation sequencing (ngs) was conducted on biopsy tissues obtained via colonoscopy prior to treatment initiation, and conversion therapies were subsequently administered. systemic treatment regimens, based on ngs results, included folfox/folfiri or folfoxiri combined with anti-egfr or anti-vegf agents, excluding those who received selective internal radiation therapy (sirt) or stereotactic body radiation therapy (sbrt). all patients were microsatellite stable (mss) and did not receive any immune checkpoint therapies such as pd-1 inhibitors. patients with locally advanced rectal cancer received additional neoadjuvant radiotherapy to the rectal area. treatment response was assessed every two cycles, and resectability of the primary tumor and metastases were evaluated post-treatment using abdominal contrast-enhanced ct and mri.

Eligibility criteria:
inclusion criteria: at diagnosis, all patients met the criteria for preoperative conversion therapy, with a cancer recurrence score (crs) of ≥3 exclusion criteria: patients were excluded if they: i) could not tolerate a full course of systemic therapy; ii) had a history of other malignancies; iii) had previously undergone cancer treatment; or iv) patients who were not rendered disease-free at time of hepatic resection (i.e., primary intact, unresected extrahepatic disease, or gross \[r2\] residual hepatic disease) were excluded.
a study to assess the safety and efficacy of su11248 in patients with gastrointestinal stromal tumor(gist)

Conditions: Gastrointestinal Stromal Tumor

Summary: a study to assess the safety and efficacy of su11248 in patients with gastrointestinal stromal tumor (gist) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.


Eligibility criteria:
key inclusion criteria: * histologically-proven diagnosis of malignant gist not amenable to surgery, radiation or combined modality treatment with curative intent * failed gleevec treatment or intolerant to gleevec therapy key exclusion criteria: * treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of gleevec
m-gcbt for women with provoked localized vulvodynia

Conditions: Provoked Localized Vulvodynia

Summary: the purpose of this study is to learn more about mindfulness based group cognitive behavior therapy (m-gcbt) as a treatment for provoked localized vulvodynia (plv). m-gcbt is a counseling technique that has been shown to reduce pain and anxiety with other medical conditions, including chronic pain conditions. the investigators wish to see if participation in m-gcbt course will help reduce anxiety, fear, and pain in women with plv greater than education alone. both techniques use a group setting including other women with plv. "mindfulness-based group cognitive behavior therapy for women with localized vulvodynia" is a study designed to learn more about the use of mindfulness based group cognitive behavior therapy for plv pain and anxiety over education alone. participants will be randomized to one of two groups: mindfulness based cognitive behavior therapy or group education seminars.

m-gcbt is a type of counseling that teaches women to have more control over their pain. educational seminars teach women about the different aspects of plv that affect emotional and physical health. both groups will be given a binder containing course material at the first session and homework at each session that you will be asked to complete. the group education seminars will include an informational video clip reviewing an aspect of plv and sexuality and will be followed by a group discussion facilitated by an instructor. each session will involve a teacher and a small group of 6 to 12 women with plv. additionally, women in both groups will be asked to perform a weekly test to measure pain and to complete a daily diary.

Eligibility criteria:
inclusion criteria: 1. reported dyspareunia for at least 6 months in non-pregnant, healthy women over aged 18-45 years old meeting friedrich's criteria for plv.51 2. qtip test51-52, 54 mean verbal rating score of ≥4/10 in 4 of 6 defined points of the vestibule (2, 4, 6, 8, 10, 12 o'clock), and have received a qtip test score of verbal ≤ 2/10 for the labia majora and minora, intra labial sulcus, and perineum. 3. ability to insert a regular tampax® tampon 4. baseline tampon test pain score ≥80mm 5. phone access 6. lives within 60 miles with reliable transportation exclusion criteria: 1. pregnancy 2. active counseling or mindfulness training (within 6 months of study) 3. any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus, etc). 4. impaired cognition or disruptive behavior not conducive to group dynamic 5. planned long term travel or surgery during study period 6. unable or unwilling to complete baseline assessments or agree to be randomized. 7. axis 2 diagnosis, chronic substance abuse, suicidality or disruptive to group dynamic 8. non-english speaking

Keywords: mindfulness group therapy vulvodynia vulvar pain
universal- versus guidelines-directed genetic testing for germline pathogenic variants utilizing a multi-gene panel for inherited cancers in non-western society.

Conditions: Genetic Predisposition

Summary: the investigators aim to study the pattern and frequency of pathogenic variants among all newly diagnosed cancer patients in a genetically distinct population. additionally, the investigators will study the uptake rate of "cascade family screening", frequency of pathogenic variants and barriers against testing.


Eligibility criteria:
inclusion criteria: * adult patient, age ≥ 18 years at time of cancer diagnosis * pathology proven diagnosis of cancer; any site, any stage (prior history of cancer is allowed) * jordanian nationality * willingness to participate * signed consent form exclusion criteria: * major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications) * non-jordanian * patients with leukemia, lymphoma and myeloma

Keywords: genetics
a multi-component program to reduce obesity in children

Conditions: Obesity

Summary: in an attempt to challenge the increasing prevalence of childhood obesity, many programs have been executed in order to improve childrens' lifestyle. programs involved either school, family or environmental measures. in most, success was only limited. the purpose of this trial is to examine the ability of a low-cost multi-component program to improve behavioral, diet and activity habits in both school, family and afternoon settings. ths ultimate goal is to construct and assess a lifestyle modification program that can be implemented in schools and kindergartens on a national level. participants will be \~2,500 children aged 5-12 from 22 kindergartens and elementary schools, divided into control and intervention centers. teachers and students will be provided with materials in order to perform activities on healthy food and drink choices and habits during the school day. schools will offer increased physical activity opportunities to children, as will afternoon community centers. children will be given personal exercise items. parents will be offered lectures on topics of diet and activity. diet and activity habits will be assessed by a questionnaire, and height, weight and body fat percentage will be measured before and after the program.


Eligibility criteria:
inclusion criteria: * schools with lunch served * school principal agreement * school has 2 weekly pe classes * parent and children consent given exclusion criteria: * consent not given

Keywords: school prevention overweight children diet physical activity fitness
first-void urine samples for the follow-up of women treated for high-grade cervical intraepithelial neoplasia (cin)

Conditions: Cervical Cancer

Summary: the aim of this study is to analyse biomarkers in first-void urine for improved follow-up of women treated for high grade cervical intraepithelial neoplasia (cin).

in total 100 women, diagnosed with cin2/3 and scheduled for lletz (large loop excision of the transformation zone), will be included in this trial. these women are asked to collect two fv urine samples with the colli-pee device (novosanis, wijnegem, belgium) prior to their treatment (one at home and one at the hospital) and at five additional time points post treatment (1-3-6-12-24 months) at home. in addition, five self-collected vaginal swabs will be taken, two before treatment (1 at home and 1 at the hospital) and three (6-12-24 months) after treatment at home. qvintip devices are used for vaginal self-sampling. during follow-up visits cervical samples and optional biopsies are collected by the physician and respectively send to the uza anatomic pathology unit to determine the patient's hpv status, cytology and histology. for the study, one extra cervical sample will be taken by the physician just before treatment, that is not part of the normal standard procedure.

Eligibility criteria:
inclusion criteria: * female (18 years and older) * scheduled for lletz treatment of diagnosed, histologically confirmed high grade cin lesions * giving informed consent to the research team (cev) to contact his/her gp and/or gynaecologist to access details of the participants hpv vaccination (schedule) and results of cervical smears/cytology, hpv tests, colposcopy, and biopsy. * not participating in another clinical study where a drug or biological is administered. * able to understand the information brochure/what the study is about.

Keywords: human papillomavirus biomarker self-sampling first-void urine cervical intraepithelial neoplasia lletz
aminophylline for patients with post-dural puncture headache

Conditions: Post-dural Puncture Headache

Summary: post-dural puncture headache (pdph) is the most common complication of lumbar puncture. its clinical manifestations are pain in the forehead and the occipital region, or diffuse headache. the pain is dull or fluctuating, becoming worse when standing and better when lying down, and is often accompanied by symptoms including a stiff neck, tinnitus, hearing loss, photophobia, and nausea, which cause great suffering to the patients1. according to epidemiological data, approximately 10% to 30% of the patients who undergo lumbar puncture suffer from pdph within 48 hours of the procedure.currently, commonly used treatments for pdph include rehydration, the administration of corticotropin, caffeine, or sumatriptan, and the application of an epidural blood patch. the efficacy of theophylline has been proven in a placebo-controlled study in which 17 pdph patients received an intravenous (iv) injection of 200 mg theophylline. the visual analogic scale scores 4 hours after treatment were significantly different compared with those of the placebo group5. at present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in china and other countries. the aminophylline for patients with post-dural puncture headache trial, is a prospective,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and safety of an iv injection of aminophylline on post-dural puncture headache.eligible patients were randomized in a blinded fashion(1:1) to receive iv injection of aminophyllineor or sterile isotonic saline.the investigators estimate that this trial will demonstrate that an iv injection of aminophylline could be the preferred method for the clinical treatment of pdph.


Eligibility criteria:
inclusion criteria: * headache has developed after the dural puncture; * pdph was defined according to the international classification of headache disorders iii (ichd-3) criteria; * the vas score of the headache was 5 or more than 5; * age between 18 and 70 years old. exclusion criteria: * a previous history of headache that could interfere with pdph diagnosis; * a history of central nervous system diseases including intracranial hemorrhage, seizures, intracranial hypertension, and hydrocephalus; * a history of cardiovascular system diseases including coronary heart disease, arrhythmias, and hypertension; * a history of peptic ulcer. * women who were pregnant, nursing, or planning a pregnancy.

Keywords: post-dural puncture headache aminophylline
n-acetyl cysteine after cervical cerclage

Conditions: Cervical Cerclage

Summary: the aim of the study is to evaluate the effect of n-acetyl cysteine (nac) on pregnancy outcome in women undergoing cervical cerclage for cervical insufficiency.

a randomized controlled clinical trial to be carried out in a university-affiliated tertiary center.participating women will be randomized into two groups: group a will be given an oral daily dose of 0.6 g of nac in effervescent form; group b, serving as controls, will not receive nac.the two groups will then be compared according to pregnancy outcome.

Eligibility criteria:
inclusion criteria: * women with history suggestive of cervical insufficiency together with ultrasound findings suggestive of cervical insufficiency undergoing elective cervical cerclage between the 11th and 12th gestational week. * singelton viable fetus exclusion criteria: * women tested positive for bacterial vaginosis * women currently with threatened abortion (vaginal bleeding or uterinecramps) * age older than 35 years or younger than 20 years * unwillingness to participate * irregular and/or uncertain menstrual dates * rupture of membranes * previous cesarean delivery * possible risks for preterm birth in the current or previous pregnancy such as twin pregnancy, iufd, malpresentation, known fetal anomaly, progesterone or heparin treatment during the current pregnancy, hypertension, and/or seizure disorders. * women with contra indications for cervical cerclage or anesthesia.

Keywords: n-acetyl cysteine (nac) cervical cerclage cervical cerclage for cervical insufficiency
icp-022 versus chlorambucil combined with rituximab in the treatment of untreated cll/sll

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this is a randomized, multicenter, open-label, phase 3 study to evaluate the efficacy and safety of icp-022 versus chlorambucil plus rituximab in subjects with previously untreated chronic lymphocytic leukemia.


Eligibility criteria:
key inclusion criteria: 1. male or female, age ≥65 years old or age \>18 years old or \ 18 years old or \ 6;b. creatinine clearance at 30-69 ml/ min (cockcroft-gault assessment) 2. enhanced computed tomography/magnetic resonance imaging (ct/mri) detection had measurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm and had a measurable vertical dimension 3. ecog physical strength score is 0-2. 4. expected survival time \>6 months. 5. voluntary written informed consent prior to screening. key exclusion criteria: 1. patients with stroke or intracranial hemorrhage in the first 6 months were randomly assigned. 2. hypersensitivity to icp-022, nitrogen mustard benzoate, rituximab or any other component of the applicable study drug. 3. any mental or cognitive impairment that may limit their understanding of the informed consent, their implementation and their compliance with the study. 4. pregnant and lactating women, or subjects of childbearing age who do not want to use contraception within 180 days from the end of the study period to the end of the study period. 5. conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator. note: other protocol defined inclusion/exclusion criteria may apply.
robotic versus laparoscopic liver resection for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the objective of the study is to investigate the long-term outcomes of minimally invasive liver surgery (robotic vs laparoscopic) for hepatocellular carcinoma patients of stage bclc 0-a. data from two tertiary centers for liver surgery will be retrospectively reviewed. patients will be divided in two cohorts (robot; laparoscopy). the primary endpoint will be recurrence-free and overall survival; secondary endpoints were incidence, pattern, and treatment of recurrences.


Eligibility criteria:
inclusion criteria: * patients undergoing robotic and laparoscopic resections * histology-confirmed hcc of stage bclc 0-a * preserved liver function (child score a-b) * patients \>18 years old exclusion criteria: * hand-assisted procedures * non-elective surgery * intraoperative switch to locoregional therapies (like radiofrequency or microwave ablation) * non-histologically confirmed hcc * mixed hepato-cholangiocarcinoma.